Manufacturing and Production

Cleaning Validation and Cross Contamination Control

A plant that makes more than one product has to prove that the previous product does not appear in the next one, and the proof rests on a limit that must be justified toxicologically rather than chosen for convenience. This course covers building that case. Delegates work through cross contamination routes in shared facilities, including equipment, air handling, operators and tooling. Health based exposure limits are addressed, covering permitted daily exposure and the derivation that supports an acceptance limit. Worst case product and equipment selection follow, including the grouping and bracketing that make a programme manageable. Cleaning procedure development is covered, since a procedure that cannot be executed the same way twice cannot be validated. Sampling methods follow: swab, rinse, recovery studies and the sites that are genuinely hardest to clean. Analytical methods and detection limits are addressed. Campaign manufacture, changeover and dedicated equipment decisions follow. The course closes on continued verification and on inspection findings.